Hernias are abnormal protrusions of an organ (or organs) through a defect or natural opening in a covering membrane, muscle or bone. Most hernias protrude in the inguinal region as inguinal (direct or indirect) or femoral hernias and in the anterior abdominal wall region, as incisional, umbilical, epigastric or Spigelian hernias.
Hernia repair may require surgery. A small defective gap may be closed by sutures, and in cases of a larger defective gap, a mesh-sheet (or mesh, for short) may be applied over the gap. In some cases a mesh-sheet may be used for reinforcing a primary sutured defect in the abdominal wall. The mesh-sheet is fixed with sutures at peripheral edges thereof to the abdominal wall.
Tools have been developed to assist deploying and placing mesh-sheets in a laparoscopic procedure. For example, U.S. Pat. No. 5,464,403 describes a tool for the placement of a flexible sheet in laparoscopic procedures. The tool includes an elongate tubular assembly and an elongate tubular member having a bore. A rod is disposed in the bore and terminates short of the distal extremity of the elongate tubular assembly. A rotatable member is secured to the proximal extremity of the rod. A handle is secured to the proximal extremity of the elongate tubular assembly and receives the rotatable member. The tubular assembly has a slot extending longitudinally which permits access to the annular chamber and the extremity of the rod. The distal extremity of the rod engages one edge of the sheet, hence as the rod is rotated in one direction, the sheet of mesh unwound from the rod and into the patient.
U.S. Pat. No. 5,957,939 describes a medical device for deploying surgical fabric such as mesh-sheet within a body cavity of a patient. The device includes a deploying member and a clamping member supported at the distal end of the deploying member for holding the fabric in rolled and unrolled configurations. The clamping member is engageable with a portion of a piece of surgical fabric and rotatable with respect to the deploying member so that the fabric in the unrolled configuration can be wrapped around the clamping member to the rolled configuration. The device further includes a self-unwinding member at the distal end of the deploying member, the self-unwinding member being effective in automatically unwinding the fabric from the rolled configuration to the unrolled configuration.
The above mentioned patents refer to means for deploying a mesh sheet but no reference is made to placing the mesh-sheet in its position within the abdominal cavity.
PCT published patent application WO 2004/080348 to the present inventor, the disclosure of which is incorporated herein by reference, describes apparatus that includes a rod formed with a handle portion and a coaxial roller portion. The mesh-sheet is wound around the roller portion. In one application the roller portion has a distal end provided with a tissue-anchoring stud. The roller portion may be rotatably attached to the handle portion. The rear edge of the mesh-sheet is detachably attached to the roller portion of the apparatus, such as with surgical threads or by any other means such as adhesive material, and the mesh-sheet is wound around the roller portion before use.
The roller portion of the rod with the mesh-sheet wound therearound is placed into a cannula and inserted through an incision into the body. The tissue-anchoring stud at the distal end of the roller portion is anchored to the tissues, e.g., by stabbing, which facilitates unrolling the mesh-sheet and positioning the rear edge of the mesh-sheet.
The mesh-sheet is placed within the abdominal cavity or inguinal space by pulling the surgical threads of the leading edge towards a pre-determined position within the cavity/space to thereby cover the hernial defect. This is achieved by suitable forceps used for manipulating the needles. The needles provided at the ends of the surgical threads are then used for stitching to the appropriate tissues of the patient, possibly by piercing the tissues of the patient from the abdominal cavity to the outside of the patient. During the stage of pulling the leading edge of the mesh-sheet by the surgical threads, the rod remains stationary and the roller rotates freely to enable smooth and easy deployment and positioning of the mesh-sheet over the hernial defect.
To conclude the hernia repair, the corners of the mesh-sheet are stitched to the body of the patient, or otherwise attached, e.g. by stapling, etc. and the surgical threads are cut and discarded. The mesh-sheet is then detached from the roller portion of the rod whereby the rod may be removed.